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FDA Brain Simulator Will Allow Evaluation Of Electrostimulation Devices On Human Nerve Cells

FDA's device center is developing computational models of the human brain to help regulators and device designers assess the physiological effects of electromagnetic fields – such as those generated by implanted nerve stimulators – on the nervous system.

With contractor proposals in hand, FDA is poised to pick a computational model simulating the brain’s reaction to electromagnetic fields. The agency's device center expects the model to help pre-market reviewers quickly assess the safety and efficacy of implanted nerve stimulators, transcranial magnetic stimulators and magnetic resonance imaging devices.

The model should also prove useful to researchers and manufacturers, as the agency plans to make it available to the...

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